System Engineer

at  Prenuvo

ABOUT US

At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience of our clinics across North America, have allowed us to lead the charge against “we caught it too late again.” Prenuvo operates preventative screening clinics in Vancouver, Silicon Valley, Dallas, Houston, Boca Raton, Minneapolis, Los Angeles, New York City, Buffalo, Bethesda, Chicago, and Atlanta, with more clinics in North America and internationally in the next 2 years.
We are looking for a System Engineer to lead the design and development of systems supporting AI-driven diagnostic tools, ensuring they comply with medical device regulations.
Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people’s lives!

OUR VALUES

First: we are Pioneers

• Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.

Second: we are Platform-Builders

• We’re always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what’s ahead – in a mindset of ownership and duty to our mission.

Above all: we are Patients

• We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients’ lives, and we won’t stop till everyone can benefit from our work.

• Lead the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with relevant medical device regulations and standards (e.g., ISO 13485, IEC 62304)
• Collaborate with cross-functional teams, including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance, to ensure seamless integration of system requirements
• Develop and maintain system architecture that ensures scalability, reliability, and compliance with safety and performance standards
• Define and document system requirements, functional specifications, risk management strategies, and validation procedures
• Conduct risk assessments and manage risk mitigation activities related to system safety and performance
• Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD
• Oversee verification and validation testing, ensuring traceability from requirements to system performance
• .Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance
• Stay current with technological advancements, industry trends, and evolving regulatory requirements for medical devices
• Develop design control documentation, including system requirements, design reviews, and traceability matrices
• Support post-market surveillance activities, including software updates, patches, and enhancements